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ChromaDex Secures U.S. Patent for the Composition of Matter of Salt Forms of NMNH (Dihydronicotinamide Mononucleotide), a Precursor to NAD+

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ChromaDex Corp. (NASDAQ:CDXC) has secured U.S. Patent number 10,000,520 C1 for the composition of matter of salt forms of NMNH (dihydronicotinamide mononucleotide), a precursor to NAD+. This patent, co-owned with Queen's University Belfast, grants ChromaDex exclusive rights to the disodium salt form of NMNH. The company now has over 80 patents related to NAD+ precursors, including its flagship ingredient Niagen® (nicotinamide riboside).

NMNH is distinct from NMN, which was banned as a dietary supplement by the FDA in 2022. While NMNH has shown promise in preclinical studies, further research is needed to determine its oral bioavailability and safety as a dietary supplement. Currently, NMNH's legal status as a dietary supplement is questionable due to lack of proper FDA notification as a new dietary ingredient (NDI).

ChromaDex Corp. (NASDAQ:CDXC) ha ottenuto il brevetto statunitense numero 10.000.520 C1 per la composizione di materia delle forme saline di NMNH (mononucleotide di diidronicotinamide), un precursore del NAD+. Questo brevetto, co-proprietà con la Queen's University di Belfast, concede a ChromaDex diritti esclusivi sulla forma salina disodica di NMNH. L'azienda possiede ora oltre 80 brevetti relativi ai precursori del NAD+, incluso il suo ingrediente di punta Niagen® (riboside di nicotinamide).

NMNH è distinto da NMN, che è stato vietato come integratore alimentare dalla FDA nel 2022. Sebbene l'NMNH abbia mostrato promesse in studi preclinici, è necessaria ulteriore ricerca per determinare la sua biodisponibilità orale e la sicurezza come integratore alimentare. Attualmente, lo stato legale dell'NMNH come integratore alimentare è discutibile a causa della mancanza di un'adeguata notifica FDA come nuovo ingrediente alimentare (NDI).

ChromaDex Corp. (NASDAQ:CDXC) ha obtenido la patente estadounidense número 10.000.520 C1 para la composición de materia de las formas salinas de NMNH (mononucleótido de dihidronicotinamida), un precursor del NAD+. Esta patente, co-propiedad con la Universidad Queen's de Belfast, otorga a ChromaDex derechos exclusivos sobre la forma salina disódica de NMNH. La compañía ahora posee más de 80 patentes relacionadas con los precursores del NAD+, incluido su ingrediente principal Niagen® (ribósido de nicotinamida).

NMNH es distinto del NMN, que fue prohibido como suplemento dietético por la FDA en 2022. Si bien el NMNH ha mostrado potencial en estudios preclínicos, se necesita investigar más para determinar su biodisponibilidad oral y seguridad como suplemento dietético. Actualmente, el estado legal del NMNH como suplemento dietético es cuestionable debido a la falta de notificación adecuada por parte de la FDA como nuevo ingrediente dietético (NDI).

ChromaDex Corp. (NASDAQ:CDXC)는 NAD+의 전구체인 NMNH(디하이드로니코틴아미드 모노뉴클레오타이드)의 염 형태에 대한 물질 조성에 대해 미국 특허 번호 10,000,520 C1을 확보했습니다. 이 특허는 벨파스트의 퀸스 대학교와 공동 소유하며, ChromaDex에 NMNH의 디소듐 염 형태에 대한 독점권을 부여합니다. 이 회사는 이제 Niagen®(니코틴아마이드 리보사이드)을 포함하여 NAD+ 전구체와 관련된 80개 이상의 특허를 보유하고 있습니다.

NMNH는 2022년 FDA에서 식이 보충제로 금지된 NMN과 구별됩니다. NMNH는 전임상 연구에서 유망한 결과를 보였지만, 식이 보충제로서의 경구 생체이용률과 안전성을 결정하기 위해 추가 연구가 필요합니다. 현재 NMNH의 식이 보충제로서의 법적 지위는 새로운 식이 성분(NDI)으로서 적절한 FDA 통지가 부족하여 의문시되고 있습니다.

ChromaDex Corp. (NASDAQ:CDXC) a obtenu le brevet américain numéro 10.000.520 C1 pour la composition de matière des formes salines de NMNH (mononucléotide de dihydronicotinamide), un précurseur du NAD+. Ce brevet, co-détenteur avec l’Université Queen's de Belfast, accorde à ChromaDex des droits exclusifs sur la forme saline disodique de NMNH. L’entreprise possède désormais plus de 80 brevets relatifs aux précurseurs du NAD+, y compris son ingrédient phare Niagen® (riboside de nicotinamide).

NMNH est distinct du NMN, qui a été interdit en tant que complément alimentaire par la FDA en 2022. Bien que le NMNH ait montré des promesses dans des études précliniques, des recherches supplémentaires sont nécessaires pour déterminer sa biodisponibilité orale et sa sécurité en tant que complément alimentaire. Actuellement, le statut légal du NMNH en tant que complément alimentaire est incertain en raison d'un manque de notification appropriée par la FDA en tant que nouvel ingrédient diététique (NDI).

ChromaDex Corp. (NASDAQ:CDXC) hat das US-Patent Nummer 10.000.520 C1 für die Stoffzusammensetzung von Salzformen von NMNH (Dihydronicotinamid-Mononukleotid), einem Vorläufer von NAD+, gesichert. Dieses Patent, das gemeinsam mit der Queen's University Belfast gehalten wird, gewährt ChromaDex exklusive Rechte an der disodium Salzform von NMNH. Das Unternehmen besitzt jetzt über 80 Patente, die sich auf NAD+-Vorläufer beziehen, einschließlich seines Hauptinhaltsstoffes Niagen® (Nicotinamidribosid).

NMNH unterscheidet sich von NMN, das 2022 von der FDA als Nahrungsergänzungsmittel verboten wurde. Während NMNH in präklinischen Studien vielversprechend aussieht, sind weitere Untersuchungen erforderlich, um seine orale Bioverfügbarkeit und Sicherheit als Nahrungsergänzungsmittel zu bestimmen. Derzeit ist der rechtliche Status von NMNH als Nahrungsergänzungsmittel aufgrund fehlender angemessener FDA-Benachrichtigung als neues diätetisches Ingredienz (NDI) fraglich.

Positive
  • ChromaDex secures a composition of matter patent for NMNH salt forms, strengthening its intellectual property portfolio
  • The patent grants exclusive rights to the disodium salt form of NMNH, potentially opening new avenues for product development
  • ChromaDex's patent portfolio now includes over 80 patents related to NAD+ precursors
Negative
  • NMNH's oral bioavailability and safety as a dietary supplement are yet to be determined
  • NMNH's legal status as a dietary supplement is questionable due to lack of proper FDA notification

The granting of this patent to ChromaDex is a significant development for the company's intellectual property portfolio. Composition of matter patents are highly valuable, offering robust protection against competitors. This patent for NMNH salt forms could potentially create new revenue streams through licensing or product development. However, it's important to note that NMNH is still in early stages, with unclear market potential.

While this strengthens ChromaDex's position in the NAD+ precursor space, investors should be cautious. The financial impact remains uncertain, as NMNH's efficacy as an oral supplement and its regulatory status are yet to be determined. The company's core product, Niagen (NR), still appears to be the primary revenue driver. This patent is more about future-proofing ChromaDex's market position than immediate financial gains.

This patent grant is an interesting development in the NAD+ precursor field. NMNH, while chemically distinct from NMN, represents a new frontier in NAD+ research. The preclinical studies showing NAD+ boosting effects of injected NMNH are promising, but there are significant hurdles to overcome.

Key questions remain: Is NMNH orally bioavailable? Is it safe for human consumption? These are important factors that will determine its viability as a dietary supplement. Moreover, its status as a new dietary ingredient (NDI) without proper FDA notification raises regulatory concerns. The scientific community will be watching closely for further research on NMNH's efficacy and safety profile. This patent positions ChromaDex well for future developments, but substantial research is still needed.

ChromaDex's newly granted patent for NMNH salt forms is a strategic legal move. Composition of matter patents provide strong protection, giving ChromaDex exclusive rights to the disodium salt form of NMNH and its derivatives. This effectively creates a legal barrier for competitors looking to develop products using these specific NMNH forms.

However, the patent's value is tempered by NMNH's current regulatory uncertainty. As a new dietary ingredient without proper FDA notification, its legal status as a dietary supplement is questionable. This could limit immediate commercialization opportunities. The patent's true value lies in its future potential, should NMNH prove viable and gain regulatory approval. It's a preemptive strike in the evolving NAD+ precursor market, but one that may take time to yield tangible benefits.

One of the most robust forms of intellectual property protection, a composition of matter patent grants ChromaDex exclusive rights to the disodium salt form of NMNH

LOS ANGELES--(BUSINESS WIRE)-- ChromaDex Corp. (NASDAQ:CDXC), the global authority on nicotinamide adenine dinucleotide (NAD+) research with a focus on healthy aging, today announced the broadening of its NAD+ precursor intellectual property portfolio with the newly granted U.S. Patent number 10,000,520 C1 covering the composition of matter for the disodium salt of NMNH (dihydronicotinamide mononucleotide). Co-owned with Queen's University Belfast (QUB), this patent solidifies ChromaDex’s leadership in the NAD+ precursor space.

ChromaDex continuously evaluates and investigates next-generation NAD+ precursors at the forefront of the burgeoning healthy aging category. The company owns and licenses a robust and secure portfolio of over 80 patents relating to its flagship patented nicotinamide riboside (NR) ingredient, Niagen®, and other NAD+ precursors including nicotinamide riboside triacetate (NRT), reduced nicotinamide riboside (NRH), nicotinic acid riboside (NAR), and now the newly granted NMNH patent.

Rob Fried, CEO of ChromaDex and Founder of Tru Niagen said, "ChromaDex continues to lead the NAD+ field commercially and scientifically, with the broadest patent portfolio of NAD+ precursors. As this industry continues to expand, we are committed to innovation and maintaining the highest production quality standards."

Not to be confused with NMN, which was banned as a dietary supplement by the U.S. FDA in 2022, NMNH is chemically distinct from NMN and a compound that has recently entered the U.S. market as an NAD+ precursor. While preclinical studies have demonstrated that NMNH can boost NAD+ levels when injected, further research is needed to determine if it is orally bioavailable and safe as a dietary supplement. Furthermore, NMNH is a new dietary ingredient (NDI) which has not been properly notified to FDA, rendering its legal status as a dietary supplement questionable at present.

One of the most robust forms of intellectual property protection, a composition of matter patent, grants ChromaDex exclusive rights to the disodium salt form of NMNH. Any company that develops a product using the disodium salt form of NMNH would infringe on ChromaDex’s patent.

In addition to the disodium salt of NMNH, ChromaDex has also obtained protection for numerous other NMNH derivatives, including metallic salts such as lithium, potassium, and magnesium. Further, the patent adds protection for salt forms of NMNH. This broadens ChromaDex’s protection and opens new avenues for future product development and commercialization.

Granted by a three-examiner panel, this patent demonstrates the diligence of ChromaDex’s innovative research and development efforts.

For additional information on ChromaDex, visit www.chromadex.com.

Forward-Looking Statements:

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, including statements related to commercial possibilities for NMNH, prospective enforcement of patent rights, and ongoing research and development efforts. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects," "anticipates," "intends," "estimates," "plans," "potential," "possible," "probable," "believes," "seeks," "may," "will," "should," "could" or the negative of such terms or other similar expressions. Risks that contribute to the uncertain nature of these forward-looking statements include the impact of the COVID-19 pandemic on our business and the global economy; our history of operating losses and need to obtain additional financing; the growth and profitability of our product sales; our ability to maintain sales, marketing and distribution capabilities; changing consumer perceptions of our products; our reliance on a single or limited number of third-party suppliers; and the risks and uncertainties associated with our business and financial condition. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, ChromaDex's Quarterly Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.

About ChromaDex:

ChromaDex Corp. (NASDAQ:CDXC) is the global authority on nicotinamide adenine dinucleotide (NAD+), with a focus on the science of healthy aging. The ChromaDex team, comprised of world-renowned scientists, works with independent investigators from esteemed universities and research institutions around the globe to uncover the full potential of NAD+. A vital coenzyme found in every cell of the human body, NAD+ declines with age and exposure to other everyday stressors. NAD+ depletion is a contributor to age-related changes in health and vitality.

Setting the benchmark as the gold standard in scientific rigor, safety, quality, and transparency, ChromaDex is the innovator behind its clinically proven flagship ingredient, Niagen (patented nicotinamide riboside, or NR), the most efficient and superior-quality NAD+ booster available.

Niagen is the active ingredient in ChromaDex’s consumer products, sold as the brand Tru Niagen®, the number one healthy-aging NAD+ supplement in the United States. Clinically proven to increase NAD+ levels, Tru Niagen is helping people around the world transform the way they age (available at www.truniagen.com).

ChromaDex’s robust patent portfolio protects NR and other NAD+ precursors. ChromaDex maintains a website at www.chromadex.com, to which ChromaDex regularly publishes copies of its press releases, news, and financial information.

Based on the top-selling dietary supplement brands by revenue per the largest U.S. e-commerce marketplace (as of 3/1/2023-2/29/2024).

ChromaDex Media Contact:

Kendall Knysch, Senior Director of Media Relations & Partnerships

310-388-6706 ext. 689

kendall.knysch@chromadex.com

ChromaDex Investor Relations Contact:

Ben Shamsian

Lytham Partners

646-829-9701

shamsian@lythampartners.com

Source: ChromaDex Corporation

FAQ

What is the new patent ChromaDex (CDXC) has secured for NMNH?

ChromaDex has secured U.S. Patent number 10,000,520 C1 for the composition of matter of salt forms of NMNH (dihydronicotinamide mononucleotide), a precursor to NAD+.

How does NMNH differ from NMN in terms of regulatory status?

NMNH is chemically distinct from NMN. While NMN was banned as a dietary supplement by the FDA in 2022, NMNH is a new compound that has recently entered the U.S. market as an NAD+ precursor. However, NMNH's legal status as a dietary supplement is questionable due to lack of proper FDA notification.

What exclusive rights does the new patent grant ChromaDex (CDXC)?

The patent grants ChromaDex exclusive rights to the disodium salt form of NMNH. Any company developing a product using this form would infringe on ChromaDex's patent.

What is the current status of research on NMNH as a dietary supplement?

While preclinical studies have shown NMNH can boost NAD+ levels when injected, further research is needed to determine its oral bioavailability and safety as a dietary supplement.

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